P.F.C. SIGMA 96-0886Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10603295234401), received between Dec 14, 2017 and Jul 1, 2026 — classified as 48 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED A SEVERE INFECTION. SO, ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC NAIL WAS PUT IN. DOI: (B)(6) 2019. DOR: (B)(6) 2026 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25678188 ↗
• InjuryJan 12, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT A FEMORAL REVISION PERFORMED DUE TO LOOSENING OF THE FEMORAL COMPARTMENT. LOOSING OCCURRED AT THE FEMORAL ADAPTER AND SLEEVE JUNCTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2016. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 24039354 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD DEVELOPED PAINFUL LAXITY OVER TIME. THE COMPONENTS APPEARED TO BE WELL FIXED. A REVISION KNEE WAS SCHEDULED TO ADDRESS LAXITY. DURING THE OPERATION, IT WAS NOTED THAT THERE WAS METAL DEBRIS BEING GENERATED BY THE PROSTHESIS AS THERE WAS STAINING THROUGHOUT THE CAPSULE. THE FEMORAL COMPONENT WAS REMOVED, AND IT APPEARED THAT THE DEBRIS WAS BEING GENERATED AT THE TAPER BETWEEN THE FEMORAL ADAPTER AND THE FEMORAL SLEEVE; BOTH OF WHICH WERE WELL FIXED. THE WELL-FIXED TIBIAL TRAY WAS REMOVED. TRIALS WERE PLACED AND MOTION AND STABILITY WAS CONFIRMED. FINAL COMPONENTS WERE PLACED. NO PATIENT HARM NOR DELAY WAS NOTED. PATIENT APPEARED HAVE HAD THICKER INSERTS PLACED ON (B)(6) 2020 AND (B)(6) 2021. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23543615 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD DEVELOPED PAINFUL LAXITY OVER TIME. THE COMPONENTS APPEARED TO BE WELL FIXED. A REVISION KNEE WAS SCHEDULED TO ADDRESS LAXITY. DURING THE OPERATION, IT WAS NOTED THAT THERE WAS METAL DEBRIS BEING GENERATED BY THE PROSTHESIS AS THERE WAS STAINING THROUGHOUT THE CAPSULE. THE FEMORAL COMPONENT WAS REMOVED, AND IT APPEARED THAT THE DEBRIS WAS BEING GENERATED AT THE TAPER BETWEEN THE FEMORAL ADAPTER AND THE FEMORAL SLEEVE; BOTH OF WHICH WERE WELL FIXED. THE WELL-FIXED TIBIAL TRAY WAS REMOVED. TRIALS WERE PLACED AND MOTION AND STABILITY WAS CONFIRMED. FINAL COMPONENTS WERE PLACED. NO PATIENT HARM NOR DELAY WAS NOTED. PATIENT APPEARED HAVE HAD THICKER INSERTS PLACED ON (B)(6) 2020 AND (B)(6) 2021. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23543421 ↗
• InjuryJul 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT WAS DUE TO BONE LOSS. CONVERTED TO A DFR. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Notching

  MAUDE report 22484502 ↗
• InjuryApr 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POSSIBLE ASEPTIC LOOSENING. REMOVED ALL IMPLANTS AND CONVERTED TO ATTUNE REVISION KNEE IMPLANTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21892748 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT PATIENT HAD LOSS OF MOBILITY, DUE TO SUSPECTED HETEROTOPIC OSSIFICATION. THE PATIENT HAD A DEPUY TC3 RP REVISION KNEE. THE SZ 4 TC3 RIGHT FEMUR, 5 DEGREE BOLT, +2/-2 FEMORAL ADAPTOR, TC3 SZ 4 X 4 DISTAL AUGMENTS X2, TC3 SZ 4 X 4 POSTERIOR AUGMENT, 115 X 16 STEM AND TC3 RP SZ 4 X 12.5 INSERT WERE EXPLANTED. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 20689266 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO NICKEL ALLERGY. DOI: UNKNOWN. DOR: (B)(6), 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18570289 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO NICKEL ALLERGY. DOI: UNKNOWN. DOR: JAN 17, 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18570213 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UNDISCOVERED NICKEL ALLERGY. THEY HAD PAIN THROUGHOUT THEIR LEG, SO THE SURGEON REPLACED EVERYTHING WITH COMPETITOR IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18184873 ↗
• InjuryOct 25, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. REVISED FEMUR AND TIBIAL COMPONENTS. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18002541 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS EXPLANTED TC3 CONSTRUCT DUE TO NICKEL ALLERGY. DOI: (B)(6), 2020, DOR: (B)(6), 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17488032 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE PAIN. EVENT IS NOT SERIOUS. DATE OF IMPLANT: (B)(6) 2010. DATE OF REVISION: (B)(6) 2013. DATE OF EVENT: (B)(6) 2011. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REVISED.

  Patient problems: Pain

  MAUDE report 17412630 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE PAIN. EVENT IS NOT SERIOUS. DATE OF IMPLANT: (B)(6) 2010, DATE OF REVISION: (B)(6) 2013, DATE OF EVENT: (B)(6) 2011. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REVISED.

  Patient problems: Pain

  MAUDE report 17412587 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: ON (B)(6) 2017. DATE OF REVISION: ON (B)(6) 2023 (LEFT KNEE). TREATMENT: FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Joint Laxity; Pain; Wound Dehiscence

  MAUDE report 17180746 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INSTABILITY. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17048111 ↗
• InjuryDec 22, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE UNKNOWN COMPONENT AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT BROKE THE ADAPTOR AND ADAPTOR BOLT FOR THE SECOND TIME. BONE HAS RESORBED AROUND THE IMPLANT CREATING ALMOST A DISTAL FEMORAL REPLACEMENT SITUATION. ADAPTOR BOLT, ADAPTOR, FEMORAL COMPONENT AND INSERT WERE REMOVED LEAVING THE TIBIAL COMPONENT AND FEMORAL SLEEVE AND STEM WELL FIXED IN THE PATIENT. A HINGED COMPONENT WAS THEN PREPPED FOR AND IMPACTED INTO THE SLEEVE THAT WAS WELL FIXED IN THE BONE AND A LPS INSERT WAS INSERTED. DOI: (B)(6) 2017. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16033314 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED PATIENT WAS UNSTABLE. THE SURGEON REMOVED THE FEMORAL COMPONENTS/POLY AND REPLACED FEMORAL COMPONENTS/POLY. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15908975 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION AND LOOSENING OF THE FEMORAL & TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. REMOVAL OF ALL IMPLANTS DUE TO CEMENT COULDN'T SEE MOST NUMBERS. ONLY ABLE TO OBTAIN THE NUMBERS FROM FEMORAL STEM, TC3 RP INSERT AND THE THICK TRAY. ALL OTHER PARTS WERE COVERED BY CEMENT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2015. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12517254 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION AND LOOSENING OF THE FEMORAL & TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. REMOVAL OF ALL IMPLANTS DUE TO CEMENT COULDN'T SEE MOST NUMBERS. ONLY ABLE TO OBTAIN THE NUMBERS FROM FEMORAL STEM, TC3 RP INSERT AND THE THICK TRAY. ALL OTHER PARTS WERE COVERED BY CEMENT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2015 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12517248 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BONE FRACTURE OF MEDIAL AND LATERAL FEMORAL CONDLYLES: ABNORMAL RADIOGRAPHIC EVALUATION - LIKELY FEMORAL COMPONENT LOOSENING (UNCONFIRMED), WITH FRACTURE OF THE MEDIAL AND LATERAL CONDYLES, AND INSTABILITY EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF REVISION: 03/31/2017 (ALL COMPONENTS). DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: REVISION OF THE FEMORAL AND INSERT COMPONENTS OCCURRED ON 17/AUG/2021

  Patient problems: Fall; Joint Laxity; Limb Fracture; Pain; Swelling/ Edema

  MAUDE report 12415386 ↗
• InjuryAug 18, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ORIGINAL OPERATION WAS PERFORMED (B)(6) 2017. TIBIA WAS LEFT IN THE PATIENT. SURGEON REPLACED THE IMPLANTS WITH ANOTHER TC3 FEMUR, SLEEVE AND A BIGGER PRESSFIT STEM. THE PROCEDURE TOOK 3 ½ HOURS. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 12337181 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TKA. REMOVED IMPLANTS THAT WERE IMPLANTED (B)(6) 2020. PERFORMED WASHOUT, I&D AND IMPLANTED A ANTIBIOTIC CEMENT SPACER. DOI: (B)(6) 2020; DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12296636 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL IMPLANT EXPLANTED, CONVERT TO ANTIBIOTIC SPACER DUE TO INFECTION. POLY INSERT CHANGED ON (B)(6) 2019 FROM PREVIOUS INFECTION. DOI: (B)(6) 2019 ALL EXPLANTED PRODUCTS, DOI: (B)(6) 2019 TIBIAL INSERT, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11917903 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL IMPLANT EXPLANTED, CONVERT TO ANTIBIOTIC SPACER DUE TO INFECTION. POLY INSERT CHANGED ON (B)(6) 2019 FROM PREVIOUS INFECTION. DOI: (B)(6) 2019 ALL EXPLANTED PRODUCTS, DOI: (B)(6) 2019 TIBIAL INSERT, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11917900 ↗